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NCT00445016 Clinical Trial

Neurologic Complications in Peripheral Regional Anesthesia - An Evaluation Based on a Standardized Protocol

Nerve Block Clinical Trial

Official title:
Neurologic Complications in Peripheral Regional Anesthesia - A Clinical Follow Up Study to Evaluate the Incidence of Neurologic Complications Defined According to a Standardized Protocol Considering Motoric and Sensory Function and Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00445016
Other study ID # nd001
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 7, 2007
Last updated May 5, 2008
Start date May 2008
Est. completion date December 2008

Study information
Verified date May 2008
Source BG Unfallklinik
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

To evaluate the incidence of neurologic complications as a consequence of peripheral regional anesthesia, all patients receiving peripheral nerve blocks will be evaluated according to a standardized protocol screening pain, motoric and sensory function recovering to defined periods, and according to a study protocol defining the items.

Description:

Neurologic complications as an adverse effect occur in all types of regional anesthesia. Reviewing the literature, the incidence spreads from 0.02 up to 3 percent. The incidence remains unclear because of different types of definitions, too. In this study, we evaluate all patients receiving peripheral regional anesthesia 24 hours after block performance according to a standardized study protocol. In case of any conspicuousness concerning motoric or sensory function or pain, the patient will be evaluated again after 48 hours. Further on, in case of neurologic dysfunction, periods of investigation will be after 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year. This study includes the definition for nerve damage concerning motoric and sensory neural function and pain.

The patients will be recruited among all patients from our hospital receiving continuous peripheral regional anesthesia.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1000
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years and older
Eligibility Inclusion Criteria:

- All patients receiving peripheral regional anesthesia

Exclusion Criteria:

- Missing agreement

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• peripheral regional anesthesia
evaluation and description of adverse effects

Locations
Country Name City State
Germany BG Unfallklinik Murnau Bayern

Sponsors (1)
Lead Sponsor Collaborator
BG Unfallklinik

Country where clinical trial is conducted

Germany, 

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